CeQur® Announces Exciting Advancements: 2 Recent FDA Clearances and New Clinical Evidence to be Presented at ADA

Extended 7-Day Wear and 1-Unit Dosing Clearances, and Two ADA Posters Signal a New Standard for Mealtime Insulin Management

HORW, Switzerland, June 4, 2026 /PRNewswire/ -- CeQur^®, the company dedicated to simplifying mealtime insulin delivery for people living with diabetes, today announced two recent FDA clearances for CeQur Simplicity^™: extended wear of up to seven days and a new 1-unit (1U) device. The company will also present two clinical posters at the 86th American Diabetes Association (ADA) 2026 Scientific Sessions reinforcing the device's real-world impact of simplifying insulin delivery. Together, these milestones reflect CeQur's growing clinical, regulatory, and commercial momentum as it works to make mealtime insulin management simpler and more effective for patients and the healthcare providers who treat them.

Recent FDA Clearances: Up To 7-Day Wear and 1-Unit Dosing

CeQur Simplicity has received 2 recent FDA clearances that expand its clinical utility and patient applicability.  These clearances will enable an expansion of the CeQur Simplicity portfolio of products that will allow healthcare providers more flexibility to treat a wider array of patients.

• Up to 7-Day Wear: CeQur Simplicity is now FDA-cleared for up to seven continuous days of wear, extended from the previous four-day maximum wear duration. For many patients, this will further reduce the burden of their mealtime insulin dosing regimens by enabling fewer device changes for a given volume of insulin.
• 1-Unit Dosing: FDA's clearance of an additional 1U dosing device gives clinicians a more precise titration tool, enabling more individualized insulin regimens. This is particularly relevant for patients requiring tighter glycemic control or those having lower mealtime insulin needs.

"These clearances address specific clinical feedback we have received from physicians and patients since launch," said Bradley Paddock, CEO of CeQur. "Extending wear up to seven days and enabling 1-unit dosing are not incremental updates; they expand who CeQur Simplicity can help and how clinicians can prescribe it. When you couple these clearances with our real-world data, and commercial expansion, the picture is clear: CeQur Simplicity is becoming the proven alternative to multiple daily injections."

Clinical Evidence: Two Posters at the ADA 86th Scientific Sessions

CeQur will present two clinical research posters with new real-world data in 1,073 Adults at the ADA 86th Scientific Sessions in New Orleans, Louisiana taking place June 5–8, 2026. Healthcare providers and attendees are invited to visit the posters (listed below) or CeQur at Booth #1205 to review the real-world evidence and learn more about the clinical findings being presented at the ADA 86th Scientific Sessions.

Posters being presented include:

• Advancing Diabetes Care by Simplifying Insulin Delivery — Poster #1865-P
• Lowering Diabetes Treatment Burden Through a Simple Switch to Insulin Patch Therapy — Poster #1867-P

About CeQur Simplicity^™

CeQur Simplicity is a convenient, discreet, and injection-free wearable insulin patch that simplifies mealtime dosing. The patch is clinically proven to improve glycemic control, with patients achieving significantly improved A1C¹ and time-in-range goals². For people over 21 years of age with diabetes.

Learn more at MyCeQurSimplicity.com or call 1-888-55-CEQUR.

About CeQur^®

CeQur commercializes advanced, simple-to-use insulin-delivery devices that make it easier for people living with diabetes to adhere to therapy and stay in control of their disease. The Company's simple, wearable devices provide freedom from multiple daily insulin injections.

1. Bergenstal R, Peyrot M, Dreon D, Aroda V, Bailey T, Brazg R, Frias J, Johnson M, Klonoff D, Kruger D, Ramtoola S, Rosenstock J, Serusclat P, Weinstock R, Naik R, Shearer D, Zraick V, Levy B. 2019. Implementation of Basal–Bolus Therapy in Type 2 Diabetes: A Randomized Controlled Trial Comparing Bolus Insulin Delivery Using an Insulin Patch with an Insulin Pen. Diabetes Technology and Therapeutics 21 (5):1-13.
2. Bergenstal R., et al Comparing Patch vs Pen Bolus Insulin Delivery in Type 2 Diabetes Using Continuous Glucose Monitoring Metrics and Profiles; Journal of Diabetes Science and Technology 1–7, 2021

SOURCE CeQur Corporation